Whistleblower Lawsuit Puts Spotlight On FDA Technical Reviews

The integrity of the scientific review process appears to be at the heart of recent allegations that Food and Drug Administration (FDA) officials spied electronically on whistleblowers—including scientists, an engineer, and a statistician—trying to expose alleged flaws in the agency's approval process for cancer-screening devices.

Six former and current FDA employees last week filed a lawsuit in federal court alleging that the agency used spyware to take screenshots of employees' personal e-mail accounts, and also retaliated against them in a number of ways for leaking documents to Congress and the press, including terminating their employment.

On Tuesday, U.S. Senator Charles Grassley (R-IA) the senior Republican on the Senate Committee on the Judiciary sent a stern letter to FDA Commissioner Margaret Hamburg reminding the agency that interfering with such disclosures to Congress is illegal. It also asks the agency to answer a number of questions about the affair, including who authorized any surveillance and whether such monitoring is still occurring.

The lawsuit filers include two licensed doctors, one M.D./Ph.D., one other scientist, an engineer, and a statistician, all of whom sat on scientific review committees for the Center for Devices and Radiological Health, which judges the efficacy of cancer-screening devices. The lawsuit alleges that senior FDA officials approved certain devices despite poor scientific reviews. The lawsuit mentions just a few devices—most prominently, one for colon cancer and one for breast cancer—but the complaints stretch to more than 10 different devices overall, says Stephen Kohn, the lead counsel for the filers and the director of the National Whistleblowers Center. Kohn added that in at least one case, officials pressured an engineer to change the warning labels on a device, removing negative language. (The FDA declined to comment on any aspect of the allegations because the lawsuit is pending.)

The whistleblowing began in October 2008, when FDA employees complained to Congress. Nine employees, later dubbed the "FDA nine" by FDA officials, next sent a letter to then-President-elect Barack Obama in January 2009 further detailing their complaints. Specifically, they said that "since 2006, FDA physicians and scientists have recommended five times not to approve mammography CAD [computer-aided detection] devices" because they failed to detect breast cancer and led to invasive and unnecessary follow-up work. FDA managers pushed for approving the devices anyway, allegedly "ordering, coercing, and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along."

In March 2009, FDA asked another physician (not part of the FDA nine) to review a colonoscopy device that used computed tomography (CT). The CT device already had FDA approval for some applications, but the manufacturer wanted it used as a general, population-wide screening tool for colon cancer. The physician rejected this use, arguing that the device did not work well and that, because each examination involved getting the equivalent of 800 x-rays, the device might actually cause a small increase in cancer. The FDA approved the device, and the physician complained vociferously.

According to the lawsuit and Freedom of Information Act requests filed by the plaintiffs, at some point during the controversy FDA officials began capturing screenshots of the computers of the people who raised complaints, including screenshots of e-mail programs like Gmail. The monitoring continued for at least 2 years, according to the lawsuit, and Kohn says the captured e-mails included not only whistleblowing business but private messages, including a picture of someone's dog. (When users log in, FDA computers do present a warning noting that employees should have "no reasonable expectation of privacy.")

Kohn claims that FDA managers took the screenshots to determine who the whistleblowers consulted with and where they got their information, and then to widen surveillance to those other people. He says the government has used such tactics before with Central Intelligence Agency and National Security Agency employees suspected of leaking documents with national security implications, but never before for scientific cases. "It's the first time we've seen heightened surveillance for health and safety issues," he says. "And it will have a chilling effect. Maybe the public doesn't need to know about how many spies we have in Iran, but they do need to know if a device will increase cancer risks."

The lawsuit alleges that the FDA also used the screenshots to harass scientists. FDA officials asked the Department of Health and Human Services' Office of Inspector General about the possibility of opening a criminal suit against one whistleblower for releasing unauthorized information. The office rejected the idea. The employee (who worked for the FDA through another agency) later lost his job despite "exceptional" or "fully successful" performance reviews in the previous 3 years, said the U.S. Office of Special Counsel.

Kohn said that his clients learned about the screenshots only this past December, and that the revelation triggered the lawsuit.